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Clinical Trial Details

Trial ID: L2209
Source ID: NCT01106625
Associated Drug: Canagliflozin
Title: The CANTATA-MSU Trial (CANagliflozin Treatment And Trial Analysis - Metformin and SUlphonylurea)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01106625/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Canagliflozin|DRUG: Placebo|DRUG: Metformin|DRUG: Sulphonylruea
Outcome Measures: Primary: Change in HbA1c From Baseline to Week 26, The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change., Day 1 (Baseline) and Week 26 | Secondary: Percentage of Patients With HbA1c <7% at Week 26, The table below shows the percentage of patients with HbA1c\<7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage., Week 26|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26, The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change., Day 1 (Baseline) and Week 26|Percent Change in Body Weight From Baseline to Week 26, The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change., Day 1 (Baseline) and Week 26|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26, The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change., Day 1 (Baseline) and Week 26|Percent Change in Triglycerides From Baseline to Week 26, The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change., Day 1 (Baseline) and Week 26|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26, The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change., Day 1 (Baseline) and Week 26
Sponsor/Collaborators: Sponsor: Janssen Research & Development, LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 469
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2010-05
Completion Date: 2012-04
Results First Posted: 2013-05-29
Last Update Posted: 2013-06-20
Locations: Huntsville, Alabama, United States|Little Rock, Alaska, United States|Phoenix, Arizona, United States|Chino, California, United States|Fair Oaks, California, United States|Roseville, California, United States|Wes Hills, California, United States|Waterbury, Connecticut, United States|Jacksonville, Florida, United States|New Port Richey, Florida, United States|Ocala, Florida, United States|St Petersburg, Florida, United States|West Palm Beach, Florida, United States|Augusta, Georgia, United States|Roswell, Georgia, United States|Chicago, Illinois, United States|Lexington, Kentucky, United States|New Orleans, Louisiana, United States|Reisterstown, Maryland, United States|Olive Branch, Mississippi, United States|Saint Louis, Missouri, United States|Westfield, New York, United States|Greenville, North Carolina, United States|Cincinnati, Ohio, United States|Tulsa, Oklahoma, United States|Medford, Oregon, United States|Altoona, Pennsylvania, United States|Harleysville, Pennsylvania, United States|Levittown, Pennsylvania, United States|Sellersville, Pennsylvania, United States|Greer, South Carolina, United States|Bryan, Texas, United States|Dallas, Texas, United States|Desoto, Texas, United States|Salt Lake City, Utah, United States|South Burlington, Vermont, United States|Wenatchee, Washington, United States|Freemantle, Australia|Heidelberg Heights, Australia|Meadowbrook, Australia|Nedlands, Australia|Wollongong, Australia|Aalst, Belgium|Bonheiden, Belgium|Edegem, Belgium|Leuven, Belgium|Corbeil Essonnes, France|La Rochelle, France|Le Creusot, France|Poitiers, France|Venissieux, France|Guatemala, Guatemala|Balatonfured, Hungary|Budapest, Hungary|Győr, Hungary|Zalaegerszeg, Hungary|Haifa, Israel|Holon, Israel|Jerusalem, Israel|Tel Aviv, Israel|Guadalajara, Mexico|Monterrey, Mexico|Carolina, Puerto Rico|Trujillo Alto, Puerto Rico|Arkhangelsk, Russian Federation|Saint Petersburg, Russian Federation|Samara, Russian Federation|Alicante, Spain|Almeria, Spain|Malaga, Spain|Sevilla, Spain|Valencia, Spain|Belfast, United Kingdom|Bolton, United Kingdom|Liverpool, United Kingdom|Manchester, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01106625